Quality System Specialist (m/f/d)

My duties

• Responsible for the proper functioning of the Quality Management System (QMS), developing processes and writing procedures and to support the development and improvement of the QMS
  
• Ensure the organization and control of documentation and validation of documents (SOP, WI, Forms, Labels, IFUs, Surgical techniques)
• Ensure the respect of the NC management process and the validation of NC
• Participate in the CAPA management process
• Participate in the realization of internal and supplier audits. Participates in external quality audits
• Perform quality related training such as QMS, GDP, and other specific topics
• Support the preparation and maintenance of registration files, participate in regulatory monitoring
• Replacement of activities related to product quality and regulatory affairs
• Participation in computerized system validations

My qualifications

• Experience in quality systems, ideally in the field of medical devices
• Experience in ISO13485 and ideally in 21CFRpart820
• Fluency in English and French

My benefits

• Diversified activities in a dynamic environment

About Hays

My contact at Hays

Reference number
587277/1

Contact
Phone: +41 44 225 50 00
E-Mail: positionen@hays.ch